Introduction to Pharmacy Practice

Introduction to Pharmacy Practice Chapter 3: Community and Ambulatory Care Pharmacy Practice

Learning Outcomes • Describe history of pharmacy practices • Describe differences among practice sites • Describe importance of communication • Explain various steps in filling a prescription • Identify trends in pharmacy practices • Describe evolving role of technician in pharmacy practices

Key Terms • Adverse reaction • Ambulatory pharmacy • Brand-name drug • Chain pharmacy • Clinic pharmacy • Community pharmacy • Copayment (copay) • Dispensing

Key Terms • Drug interactions • Formulary • Health Insurance Portability and Accountability Act (HIPAA) • Independent pharmacy • Managed care pharmacy • Mail-order pharmacy • Medication guides

Key Terms • National Drug Code (NDC ) • Over-the counter (OTC) drugs • Patient counseling • Prescription • Reimbursement • Third-party payer

History of Pharmacy Practice • Community pharmacies-1st pharmacies • Ambulatory care pharmacies • for walk-in patients • evolved from community pharmacies • usually located in close proximity to clinics, hospitals, or medical centers • provide prescription services & limited number of OTC medications

History of Pharmacy • Pharmaceutical remedies were limited • Pharmacists • prepared, or compounded remedies • used natural sources & raw chemicals • No regulations on drugs • Pharmacists compounded remedies • based on • patient’s evaluation & diagnosis • patient’s symptoms or requests

Key Legislation • 1938-Food, Drug, and Cosmetics Act (FDCA) • required pre-market approval for new drugs (safety) • Prohibited false therapeutic claims for drugs • “Prescription–only” drug designation per manufacturer • 1951-Durham-Humphrey Amendment to FDCA • “Prescription–only” drug designation based on safety & potential for addiction • Two categories of drugs were established: • legend drugs=rx drug • over-the-counter (OTC)

1950’s-1980’s • 50’s Focus on pharmacist dispensing • information about prescriptions limited to doctor-patient relationships • inappropriate for pharmacist to discuss drug therapy with patient • 60’s-70’s Drug interactions /adverse reactions • more drugs on market • pharmacies began maintaining patient profiles • 80’s Pharmaceutical care was gaining wider acceptance

3rd Party Payers • Examples: • government employers • government programs • Medicaid • employers’ health insurance policies • private insurance purchased by individuals • Effects: • decreased reimbursement for pharmacies • restricted drugs covered • control of copays

OBRA • 1990-Omnibus Budget Reconciliation Act • Required pharmacists to perform 3 functions for Medicaid prescriptions : • Prospective drug utilization review (DUR) • Patient counseling • Patient record maintenance • Now these functions performed for all prescriptions

Pharmacy Technicians • Role of pharmacist • evolved from preparers of drug products to dispensers of drug products • managers of medication therapies • Role of pharmacy technicians • assumed technical functions drug distribution • development of professional standards for technicians

Practice Sites • Community & ambulatory care pharmacy settings • community pharmacies • clinic pharmacies • managed care pharmacies • mail-order pharmacies

Community Pharmacies • Two groups • independent pharmacies • # of pharmacies declining • chain pharmacies • # of pharmacies increasing

Clinic Pharmacies • Located in clinics or medical centers • May be owned by the facility or independently • Similar to community pharmacies • more direct contact with prescribers • more involved in managing drug therapies • offer health screening & immunization services • smaller in size • limited amount of OTC medications

Managed Care Pharmacies • Owned by managed care system such as HMO • Resemble clinic pharmacies • Restricted to patients in system • Typically located in close proximity to medical facility • More coordinated communication among health care professionals

Mail-Order Pharmacies • Classified as ambulatory pharmacies • Fill very large volumes of prescriptions • Specialize in maintenance medications • Highly automated • Less direct contact with patients • telephone , or electronically, via Web sites • Like warehouses with pharmacists & technicians

Technician Responsibilities • Communicating with patients • Ensuring patient privacy • Receiving prescriptions and registering patients • Transferring prescriptions • Entering prescriptions in computer • Handling restricted-use medications • Resolving third-party payer issues • Filling & labeling pharmaceutical products • Compounding prescriptions • Collecting payment & offering patient counseling • Fulfilling miscellaneous responsibilities

Communicating with Patients • Act professionally and in a caring manner at all times • Often first and last person to interact with a patient • Patients may not feel well • Technician must • show concern for patients • respect patients’ privacy • Confrontations with patients • use calm approach • involve pharmacist

Ensuring Patient Privacy • 1996-HIPAA passed • Included “privacy rule” which is national standard • Specific guidelines for private patient information • use care when discussing private patient information • ensure documents with private information be placed in the appropriate location for destruction • written policy for handling private patient information

Receiving Prescriptions • Identify returning patient with 2 identifiers such as name and: • date of birth, address, or phone number • Registering new patients, obtain: • correct spelling of name • address and phone number(s) • insurance information from patient’s insurance card • date of birth • drug allergies • prescriptions or OTC medications the patient takes regularly • health conditions

Receiving Prescriptions • Methods of receipt • directly from patient • from prescriber via • telephone • fax • electronic transmission • Determine when patient will pick up prescription • important for customer service & workflow • process prescriptions in order of when they are due

Fill With Brand or Generic? • Generic drugs less expensive • FDA provides list of equivalent generics • state regulations vary regarding generic substitution • “Would you like us to fill your prescription with a less expensive generic alternative, if one is available?” • do not offer if prescriber has not allowed • do not offer if generic not available

Transferring Prescriptions • Subject to specific state regulations • Pharmacist is responsible for information transferred • Transfer must be accomplished only pharmacist to pharmacist in some states • Upon request for transfer • obtain information about prescription • pharmacist will use to help with transfer process

Computer Order Entry • Variety of prescription processing software • Specific steps varies among systems • Often prescription scanned into system • hard copy readily accessible at each step of filling or refilling • Information on prescription entered into appropriate fields

Restricted-Use Medications • FDA requires Risk Evaluation and Mitigation Strategy (REMS) for certain medications • determines strategy to ensure benefits outweigh potential risks • may require registration • may require other action by the physician, pharmacist, and patient • May also apply specifications for prescriptions • limits on how many units may be dispensed • if refills are allowed • stickers or other documentation on the face of the prescription

Examples of Drugs with REMS • alosetron (Lotronex) • clozapine (Clozaril, Fazaclo) • isotretinoin (Accutane, Amnesteem, Claravis, Sotret) • thalidomide (Thalomid) • dofetilide (Tikosyn)

Alosetron • Treats a type of irritable bowel syndrome (IBS) • Serious adverse reactions of gastrointestinal tract • some necessitate a blood transfusion or surgery • some even lead to death • Restricted by Prescription Program for Lotronex (PPL) • requires physician enrollment & submission of Patient-Physician Agreement Form • Prescriptions must be written by physician & must include PPL sticker on face of prescription

Clozapine • Treats patients with schizophrenia • Can cause serious drop in white blood cells • monitoring must be done regularly • Pharmacies must register to dispense clozapine • Specific day supply may be dispensed • (1, 2, or 3 weeks depending on monitoring frequency) • Pharmacy must receive documentation of blood work

Isotretinoin • Treats severe acne & can cause serious birth defects • iPledge Program • registration required by • doctors • patients • Pharmacies • must meet specific requirements / answer questions with iPledge Program each time drug dispensed • quantity dispensed is limited • prescription must be picked up within limited time

Thalidomide • Treats multiple myeloma/erythema nodosum leprosum • Causes birth defects • Thalidomide Education & Prescribing Safety (S.T.E.P.S.) Program • prescribers, patients, pharmacies must register • pharmacy must verify that the prescriber is registered with S.T.E.P.S. before dispensing medication

Dofetilide • Treats irregular heart rhythms • Can cause serious complications • Patients must be hospitalized to initiate therapy • Tikosyn in Pharmacy System (T.I.P.S.) • prescribers & pharmacists must register • pharmacy must verify the prescriber’s registration

Medication Guides • FDA designates drugs requiring MedicationGuide • patient information approved by FDA • Purposes • avoid serious adverse events • inform patient of known serious side effects • provide directions for use • promote adherence to treatment • Available for specific drugs/classes of drugs such as • Non-steroidal anti-infl ammatory drugs (NSAIDs) • Antidepressants

Third-Party Payer • 3rd party payer = someone other than patient pays • May be insurance company, federal or state government agency, employer, etc. • 3rd party claim sent electronically as Rx information entered into pharmacy computer=adjudication

Third-Party Payment • If claim is accepted • payer has agreed to pay claim • appropriate copayment for claim will be noted • copay is amount of patient is responsible for paying • copays vary among plans and could be: • percentage of the total cost of the prescription or • flat dollar amount per prescription 0r • three-tier copays

3rd Party Plans • 3-tiered system • low copay for generic drugs • higher copay for “preferred” brand name drugs • still higher copay for “non-preferred” brand name drugs • formulary • list of drugs/tiers that 3rd party payer will cover

PBMs=Pharmacy Benefit Managers • Work for multiple third-party payers • Process transactions • Help establish & enforce their formularies

Rejections from PBMs • If there is a problem with claim • pharmacy receives rejected claim message • resolving third-party rejections is time-consuming • Common rejections • missing/invalid patient ID number • refill too soon • plan limitations exceeded • prior authorization required

Resolving 3rd Party Rejections • May be resolved by simply verifying information • May require phone call to third-party payer or PBM • More information in Chapter 20

Prescription Filling & Labeling • Select correct drug product & container • correct drug • correct dose • correct dosage form • correct quantity • Package in prescription container before labeling

Manufacturer’s Containers • Manufacturers packages available in commonly dispensed quantities (e.g., 30,60, or 90) • Topical preparations, inhalers, nasal sprays • Apply prescription label to manufacturer’s package • Expiration date, lot number, storage requirements should not be covered by label

Safety • Use great care & accuracy • Mistakes present possible dangers to patient • After completing filling & labeling process re-check • correct drug • correct dose • correct dosage form • Use National Drug Code (NDC) as a double check

Technology • Counting devices may • use a scale to count units based on their weight • use light beams to count units as they are poured • bulk quantities in “cells” to dispense required number of units into vial • Devices may place label on vial • Technicians fill, clean, & maintain equipment

Compounding Prescriptions • Preparation of special formulations • simple mixtures of liquids or creams • complicated mixtures –preparing liquid form of tablet or capsule • Technicians may prepare compounded formulations under a pharmacist’s supervision in some states • “Recipe book” • ingredients • directions for preparing • storage requirements

Log of Compounds • Required in many states • Logs document • who was involved in the preparation /verification • ingredient names, • ingredient quantities • lot numbers • expiration dates • More information in Chapter 15: Nonsterile Compounding and Repackaging

Collecting Payment • Point-of-sale (POS) transactions • checking out patients /collecting payment • 4 important aspects • verify patient’s name & 2nd identifying information • legal requirements must be met regarding patient counseling. • provide privacy policy in compliance with HIPAA regulations • collect patient signature for these reasons: • required by HIPAA • in some states to document refusal of patient counseling • by 3rd -party payers to prove receipt of prescription

Miscellaneous Responsibilities • Managing inventory • Managing pharmacy records • Helping patients locate OTC drugs • questions that require clinical knowledge or judgment must be referred to a pharmacist • Pseudoephedrine sales • federal and state laws regulate quantity of OTC medications containing pseudoephedrine • technicians are allowed to process transactions under these guidelines

Practice Trends • Disease state management • Health screenings • Immunizations • Dietary supplements • Specialty compounding

Disease State Management • Clinical management of medication therapies • pharmacists collaborate with prescribers • make adjustments or changes to medications • hypertension • hyperlipidemia • asthma • anticoagulant therapy

Health Screenings • Blood pressure measurements • Blood glucose levels • Cholesterol panels • Bone density scans • Technicians may assist pharmacist

Introduction to Pharmacy Practice